|- candidate number||8430|
|- NTR Number||NTR2501|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||9-sep-2010|
|- Secondary IDs||10-069 METC MC Haaglanden|
|- Public Title||“The effect of duration of wound drainage on allogeneic blood transfusions using a postoperative retransfusion system after major orthopaedic surgery.”|
|- Scientific Title||“The effect of duration of wound drainage on allogeneic blood transfusions using a postoperative retransfusion system after major orthopaedic surgery.”|
|- ACRONYM||Drain duration in joint replacement|
|- hypothesis||A postoperative retransfusion system is most effective in terms of allogeneic blood transfusion rates when in situ for maximum of 6 hours after major orthopaedic surgery. |
|- Healt Condition(s) or Problem(s) studied||Retransfusion, Drain, Joint arthroplasty, Duration|
|- Inclusion criteria||1. Patients scheduled to undergo elective major orthopaedic surgery (hip, knee);|
2. Male and non-pregnant female patients between 18-80 years of age;
3. The individual is physically and mentally willing and able to comply with postoperative functional evaluation and able to participate in an appropriate rehabilitation schedule;
4. Patients who signed the Ethics Committee approved specific Informed Consent Form prior to surgery.
|- Exclusion criteria||1. Patients with a major surgical procedure during the 12 weeks before the study-related operation;|
2. No other used alternatives to reduce allogeneic blood transfusions, such as preoperative epoetin alpha (Eprex®) injections or intra-operative cell saving (Sangvia®);
3. Clinical or laboratory evidence of untreated iron, folate or vitamin B12 deficiency;
4. Recent Myocardial Infarction or CVA (<3 months);
5. Dutch language not mastered;
6. The patient is pregnant or planning a pregnancy after surgery (or is using inadequate birth control);
7. Mentally disabled patients;
8. Current malignancy or any active infection.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-aug-2010|
|- planned closingdate||1-jan-2013|
|- Target number of participants||570|
|- Interventions||Autologous retransfusion drainage with the Bellovac® ABT retransfusion system.
After inclusion, patients are randomised into three groups:
1. Group 1: No drainage;
2. Group 2: Drainage for 6 hours after surgery;
3. Group 3: Drainage for 24 hours after surgery.
Randomisation with sealed envelopes (stratification per clinic) will be done at the end of surgery just before wound closure. Shed blood in group 2 and 3 is collected and retransfused 6 hours after surgery. After retransfusion the drain is removed in group 2 whereas the drain is continued for drainage until drain removal the first postoperative morning.
|- Primary outcome||Allogeneic blood transfusion rate.|
|- Secondary outcome||1. Haemoglobin level (pre-operative, 24 and 72 hrs after operation);|
2. Amount of blood collected with Bellovac ABT at 6 hours and 24 hours;
3. Complications, especially wound problems;
4. Length of hospital stay;
5. Co morbidity.
|- Timepoints||1. Pre-operative;|
2. Day 1;
3. Day 3;
4. 6 weeks.
|- Trial web site||www.mchaaglanden.nl/orthopedie|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Drs. B.J.W. Thomassen|
|- CONTACT for SCIENTIFIC QUERIES||Drs. B.J.W. Thomassen|
|- Sponsor/Initiator ||MC Haaglanden, locatie Antoniushove en Westeinde|
(Source(s) of Monetary or Material Support)
|Medisch Centrum Haaglanden|
|- Brief summary||Rationale: |
Use of post operative wound drains in hip and knee arthroplasty is still debated. Drainage is said to reduce wound haematoma, improves wound healing and prevents infection. Therefore many patients are treated with wound drainage until the first postoperative day. However, it is also said that continual drainage after surgery will increase the amount of shed blood because the counteraction of haematoma formation will not take place. In addition, drains may act as access route for bacterial contamination of the wound which can cause a periprosthetic infection. This favours no drainage at all. These assumptions are based on results in patients where a drain was used as a drainage system only. However, retransfusion drainage systems after arthroplasty are gaining popularity. These retransfusion systems are used to reduce the need for allogeneic blood transfusions. It is interesting if the potential benefits outweigh the controversial thoughts in drainage. Therefore we want to evaluate whether drainage, using a retransfusion system, after major arthroplasty is useful at all.
Is the use of postoperative autologous retransfusion drainage (ARD) systems useful in hip and knee arthroplasty.
After inclusion, patients are randomised into three groups. Group 1: no drainage, group 2: drainage for 6 hours after surgery and group 3: drainage for 24 hours after surgery. Randomisation with sealed envelopes (stratification per clinic) will be done at the end of surgery just before wound closure. Shed blood in group 2 and 3 is collected and retransfused 6 hours after surgery. After retransfusion the drain is removed in group 2 whereas the drain is continued for drainage until drain removal the first postoperative morning.
570 patients planned to undergo primary total hip and knee arthroplasty fulfilling the in- and exclusion criteria will enter this study after given written informed consent.
An existing intervention will be investigated, autologous retransfusion drainage with the Bellovac® ABT retransfusion system.
Main study parameters/endpoints:
The primary endpoint is the amount of allogeneic blood transfusions in the three groups. Allogeneic blood transfusions are given by specific haemoglobin levels. Secondary endpoints are haemoglobin levels in the perioperative period, and complications with special focus on wound healing disturbances after surgery. Furthermore, all clinical data will be collected such as length of hospitalisation, co morbidity and others.
Nature and extent of the burden and risks associated with participation benefit and group relatedness:
There are no potential risks or benefits related to participation in this study.
|- Main changes (audit trail)|
|- RECORD||9-sep-2010 - 19-mei-2014|